Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)

Gestational Diabetes Clinical Trial

Official title:

Descriptive Study of the Diabetes Mellitus, Type 2 Diagnosis Methods During Postpartum Period in Patients With Medical History of Gestational Diabetes Whom Benefited an Educational Therapy Session.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644004
• Other study ID #: 69HCL18_0210
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: February 13, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance.

It diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications.

Actual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. But studies reveal a low diagnosis rate.

The study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients followed in endocrinology at the hospital of Vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive.

Exclusion Criteria:

• Minor patients or under legal protection (guardianship)

• Patients who not speak french

• Patients who did not declared an attending physician

• Refusal to take part in the survey

• Patients lost to follow-up before childbirth

• Patients whose pregnancy ended by foetal death.

• Pre-existing diabet before pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.
Patients will be contacted by mail with sending of the information notice to ask them to participate in the study. If they don't reply, the subjects will be called by phone by the investigator to collect their non opposition of participation at the study. During this call, the investigator will be able to answer all the questions about the study. The report of this telephone conversation will be register in the medical file of the patient. Then, we will collect informatic data from the hospital concerning the patients. After that they will be contacted by phone to answer a survey. Beside, another secure survey will be send by email to each patient's family doctor. To finish, crossing data between those of the patients and the family doctor and anonymisation of the data.

Locations

Country	Name	City	State
France	Centre hospitalier Lucien Hussel	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performing oral glucose tolerance test in order to detect type 2 diabetes	Performing oral glucose tolerance test between 6 and 12 weeks after childbirth. As recommended by actual World Health Organisation (WHO) guidelines	Month 6